NCT06459193

Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.

Detailed description

Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits. The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment. Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN. TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.

Conditions

• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
DRUG	Trimetazidine	Trimetazidine 35 mg tab once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2024-06-23
• Primary completion: 2025-01-28
• Completion: 2025-03-27
• First posted: 2024-06-14
• Last updated: 2025-03-30

Locations

1 site across 1 country: Egypt